(93 days)
Biophen Plasma Calibrator is normal citrated human plasma used as the calibrator in the assay for the coagulation factors Antithrombin III and Protein C. The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation.
Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal citrated human plasma used as quality control of some coagulation factors. The Biophen Normal and Abnormal Control Plasma are tested for the absence of Lupus Anticoagulant and can be used as a negative control for this investigation. This control plasma is also tested for the absence of Activated Protein C resistance (APCR): when tested with or without Activated Protein C (APC), the ratio obtained (APTT + APC/APTT) is ≥ 2.00 for the Normal Control Plasma.
BIOPHEN Plasma Calibrator reagent is composed of citrated normal human plasma, lyophilised in the presence of additives and preservatives. It contains 12 vials of lyophilised reagent to be reconstituted with 1 ml distilled water.
Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal citrated human plasma used as quality control of some coagulation factors.
The provided text describes three medical devices: the Biophen Plasma Calibrator, Biophen Normal Control Plasma, and Biophen Abnormal Control Plasma. The information provided is primarily focused on their intended use, composition, and comparison to predicate devices, rather than a detailed study evaluating their performance against specific acceptance criteria.
Therefore, I cannot fully complete all sections of your request as the document does not contain the specific details of a performance study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement as you've outlined.
However, I can extract information related to the device's characteristics and its intended use, which indirectly serve as a form of "acceptance criteria" in the context of substantial equivalence to predicate devices.
Here's a breakdown based on the available information:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)
The "acceptance criteria" for these devices appear to be their ability to perform equivalently to their predicate devices for their intended uses. The document states that the devices use the same principles as the predicate devices and are "substantially equivalent in performance, intended use and safety and effectiveness."
| Acceptance Criteria / Performance Claim | Reported Device Performance | Comments |
|---|---|---|
| Biophen Plasma Calibrator: | ||
| Calibrator for ATIII assays | Substantially equivalent to predicate plasma calibrators | The document implies equivalence to established calibrators, but a specific predicate for the calibrator isn't mentioned in detail beyond "legally marketed predicate devices." Its purpose is to calibrate specific coagulation factor assays. |
| Calibrator for Protein C assays | Substantially equivalent to predicate plasma calibrators | Supports the calibration of Protein C assays. |
| Calibrator for Lupus Anticoagulant investigation | Tested for absence of Lupus Anticoagulant | Used as a calibrator for Lupus Anticoagulant investigations. |
| Biophen Normal Control Plasma: | ||
| Quality control for ATIII assays | Substantially equivalent to "Control Plasma N" (K001256) | Claims equivalent performance to the predicate device for QC of ATIII. |
| Quality control for Protein C assays | Substantially equivalent to "Control Plasma N" (K001256) | Claims equivalent performance to the predicate device for QC of Protein C. |
| Negative control for Lupus Anticoagulant investigation | Tested for absence of Lupus Anticoagulant | Claims equivalent performance to the predicate device for LA control. |
| Absence of Activated Protein C resistance | Ratio (APTT + APC/APTT) ≥ 2.00 | This is a specific performance characteristic for the Normal Control Plasma. |
| Biophen Abnormal Control Plasma: | ||
| Quality control for ATIII assays | Substantially equivalent to "Lyphochek® Hemostasis Control" (K020878) | Claims equivalent performance to the predicate device for QC of ATIII. |
| Quality control for Protein C assays | Substantially equivalent to "Lyphochek® Hemostasis Control" (K020878) | Claims equivalent performance to the predicate device for QC of Protein C. |
| Negative control for Lupus Anticoagulant investigation | Tested for absence of Lupus Anticoagulant | Claims equivalent performance to the predicate device for LA control. |
Study Details Based on the Provided Information:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify a numerical sample size for any test set.
- The data provenance is not explicitly stated as a formal "study" with a test set in the traditional sense. The submission is a 510(k) for substantial equivalence, which relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparative testing, but the details of such testing (e.g., number of samples, origin) are not provided here. The manufacturer is Hyphen Biomed, based in France.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The document does not provide information about experts establishing ground truth for a test set. This type of information is typically part of a detailed clinical or performance study report, which is not present here.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not provide information about an adjudication method.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was mentioned or implied. These devices are calibrators and controls for in-vitro diagnostic assays, not AI-assisted reading tools.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- These are reagents (plasma calibrators and controls), not algorithms. Therefore, a standalone algorithm performance study is not applicable.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For "Biophen Plasma Calibrator": The "ground truth" implicitly refers to the established values of coagulation factors (ATIII, Protein C) in normal human plasma as determined by validated laboratory methods, against which the calibrator would be standardized. For Lupus Anticoagulant, the ground truth is the absence of Lupus Anticoagulant as determined by specific testing.
- For "Biophen Normal and Abnormal Control Plasma": The "ground truth" for these controls would be their expected diagnostic values for ATIII, Protein C, and the presence/absence of Lupus Anticoagulant, and APC resistance status, established through validated assays and comparison to predicate devices and potentially reference materials. The Normal Control Plasma explicitly has a ground truth for APC resistance (ratio ≥ 2.00).
-
The sample size for the training set
- The document does not mention a "training set" as this is not an AI/machine learning device. The closest concept would be the pooled normal human plasma used in the manufacturing process (e.g., "Normal human citrated pooled plasma" for the calibrator, which contains >75% human plasma). The size of this pool is not specified.
-
How the ground truth for the training set was established
- Not applicable as there is no "training set" in the context of an AI device. The controls and calibrators are derived from pooled human plasma, and their characteristics are established through analytical testing against known standards and predicate devices.
{0}------------------------------------------------
Summary Report For Biophen Plasma Calibrator
Description:
BIOPHEN Plasma Calibrator reagent is composed of citrated normal human plasma, BIOPHEN Plasma Calibrator leagent is compose of each it contains 12 vials
lyophilised in the presence of additives and presentives unter lyophillsed in the presente of adultived with 1 ml distilled water.
of lyophilised reagent to be reconstituted with 1 ml distilled water.
Proprietary Name: Biophen Plasma Calibrator
Established Name: Plasma Calibrator
Intended use:
The Biophen plasma calibrator is used as a calibrator in the assay for the The Blophen plasma Calibrator is used as a callerator in the accorporation III & Protein C. It can be also used as normal human plasma control.
The following table shows various parameters, which are measured using the assays The lollowing table shows various paramoters, while waskage inserts:
| Assays | Reagents | Manufacturers | Reference |
|---|---|---|---|
| ATIII | Biophen | Hyphen Biomed | 221102 |
| Antithrombin | 221105 | ||
| Protein C | Biophen ProteinC | Hyphen Biomed | 221202 |
| 221205 | |||
| Lupus | DWtest® | American | 810 |
| Anticoagulant | DWconfirm® | Diagnostica | 815/815L |
DWtest, DWconfirm are registered trade marks from American Diagnostica Inc.
The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation.
Matrix Base: Stabilized reagent from human plasma
Form: Lyophilized
Volume: 1ml per vial
Composition:
Normal human citrated pooled plasma: Freeze dried powder containing human plasma >75% Hepes <10 mg Glycine < 25 mg Ciprofloxacin <0.001%
{1}------------------------------------------------
Biophen Normal and Abnormal Control Plasma Summary
(Summary of Safety and Effectiveness)
Submitted by:
Hyphen Biomed 95000 Neuville sur Oise, France Phone # 01 34 40 6510 Fax# 01 34 487236
Contact Person:
Dr. Jean Amiral, President &Scientific Director jamiral@hyphen-Biomed.com
Summary prepared by:
16th November 2004
Name of the device:
Biophen Normal Control Plasma & Biophen Abnormal Control Plasma
Classification Name:
Plasma Controls, Normal and Abnormal
Regulation#: 864.5425
Predicate Device Information:
Plasma Control N (K001256) for Biophen Normal Control Plasma 1 Jaama Control (K020878) for Biophen Abnormal Control Control Plasma
Description of the Device/intended use:
Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal citrated human plasma used as quality control of some coagulation factors.
The following table shows the various parameters which are measured using assays The lollowing table shows the varieting to be as per the package inserts.
| Assays | Reagents | Manufacturers | Reference |
|---|---|---|---|
| ATIII | Biophen ATIII | Hyphen Biomed | 221102221105 |
| Protein C | Biophen Protein C | Hyphen Biomed | 221202221205 |
| LupusAnticoagulant | DWtest®DWconfirm® | AmericanDiagnostica | 810515/815L |
{2}------------------------------------------------
The Biophen Normal and Abnormal Control Plasma are tested for the absence of The Diophen Normal and Abhormsed as a negative control for this investigation.
The Normal control plasma is also tested for the absence of Activated Protein C The Normal Control plasma is also tostos no formed with or without Activated Protein C (APC) the ratio obtained (APTT + APC/APTT) is ≥2.00.
Statement of how the technological Characteristics of the device compare to the Predicate device:
Biophen Normal control uses the same principle as the predicate Control Plasma N Diophen Normal oonlive about the performance, intended use and safety and effectiveness.
Biophen Abnormal control uses the same principle as the predicate Lyphockek®Hemostasis Control and is substantially equivalent in performance, intended use and safety and effectiveness.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
MAR 17 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
HYPHEN Biomed c/o Mr. Ola Anderson President Aniara 9944 Benningtan Drive Cincinnati, Ohio 45241
Re: K043451
Trade/Device Name: Biophen Normal Control Plasma, Biophen Abnormal Control Plasma and Biophen Plasma Calibrator
Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose Systems for In Vitro Coagulation Studies Regulatory Class: II Product Code: GGN Dated: February 14, 2005 Received: February 16, 2005
Dear Mr. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regions and ment date of the Medical Device Amendments, or to conimer of pror to 112) 20, 2011 de nocs that have t (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, alex of ovisions of the Act include requirements for annual registration, listing of general ocharely proficturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your device is elabilitional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice Of N Far 807), as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
{4}------------------------------------------------
Page 2 -
If you desire specific information about the application of labeling requirements to your device, If you destre specific infortion and advertising of your device, please contact the Office of In of quotions on are promise Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may other belief geturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
lobatz Beckerh
Robert L. Becker, Jr., MD, PM. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indication for use
510(k) number: K043451
Device Name: Biophen Plasma Calibrator
Indication for Use:
Biophen Plasma Calibrator is normal citrated human plasma used as the calibrator in Blophen Flaoma Cafer coagulation factors Antithrombin III and Protein C.
The following table shows various parameters which are measured using the assays from Hyphen BioMed or from other manufacturers as per the instructions in the package insert:
| Assays | Reagents | Manufacturers | Reference |
|---|---|---|---|
| ATIII | Biophen | Hyphen Biomed | 221102 |
| Antithrombin | 221105 | ||
| Protein C | Biophen Protein C | Hyphen Biomed | 221202 |
| 221205 | |||
| LupusAnticoagulant | DWtest®DWconfirm® | AmericanDiagnostica | 810815/815L |
DWtest, DWconfirm are registered trade marks from American Diagnostica Inc.
The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation.
Prescription Use
(Part 21 CFR 801 Subpart D)
And/or Over -The Counter use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE –CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Josephine Bautista
Page 1 of 1
Off nostie
sva
5100( K043451 5
{6}------------------------------------------------
Indications for Use
510(k) Number (if known): 043451
Device Name: Biophen Normal Control Plasma & Biophen Abnormal Control Plasma
Indications for Use:
Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal Blophen Normal and Abhoma. Och er ontrol of some coagulation factors.
The following table shows the various parameters which are measured using assays. The following table shows the various puramotors which while waskage inserts:
| Assays | Reagents | Manufacturers | Reference |
|---|---|---|---|
| ATIII | Biophen ATIII | Hyphen Biomed | 221102221105 |
| Protein C | Biophen Protein C | Hyphen Biomed | 221202221205 |
| LupusAnticoagulant | DWtest®DWconfirm® | AmericanDiagnostica | 810815/815L |
DWtest, DWconfirm are registered trade marks from American Diagnostica Inc
The Biophen Normal and Abnormal Control Plasma are tested for the absence of The Diophen Normal and Abhormand as a negative control for this investigation.
This control plasma is also tested for the absence of Activated Protein C resistance This control plasma is also tested for the about without Activated Protein C (APC), (Acc + 3 1): the ratio obtained (APTT + APC/APTT) is ≥ 2.00 for the Normal Control Plasma.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Angelina Bautista
Page 1 of 1
Divisiof
Office V
Evalu
510(k)_K043451
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.